Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer

  • STATUS
    Recruiting
  • End date
    Sep 14, 2023
  • participants needed
    138
  • sponsor
    University of Colorado, Denver
Updated on 14 July 2022

Summary

This study seeks to determine the effectiveness of Rucaparib as maintenance therapy for metastatic and recurrent endometrial cancer, after 1-2 prior lines of therapy.

Description

This is a phase II clinical trial, that administers a maintenance treatment after first line chemotherapy is complete. It is designed to have a 1:1 randomization technique. Half the participants who enter the study will receive the active ingredient, Rucaparib, while the other half will receive a placebo. Treatment will be until progression with follow up until death.

Details
Condition Metastatic Endometrial Cancer
Treatment rucaparib, Placebo Oral Tablet
Clinical Study IdentifierNCT03617679
SponsorUniversity of Colorado, Denver
Last Modified on14 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the
following criteria
Provision to sign and date the consent form
Stated willingness to comply with all study procedures and be available for the
duration of the study
Be a female aged 18-89
Patients with a primary Stage III/IV or recurrent endometrial cancer
Patients have received at least one prior chemotherapy regimen and no more than two
prior cytotoxic regimens (including hormonal therapy)
Primary chemotherapy regimen must have consisted of at least 4 completed cycles and no
more than 8 completed cycles
Previous cytotoxic regimen at least 4 weeks before initiation and no more than 8 weeks
from initiation after last dose of previous therapy
Patients who receive radiation to the whole pelvis or at least 50% of the spine must
complete radiation therapy and have at least 4 weeks' time elapse prior to initiation
of drug
ECOG performance status of 0, 1 or 2
ANC > or = 1500 cells/microliters
Platelet count > 100,000 microliters
Hemoglobin > or = 9.0 g/dL
Serum albumin > or = 2.5 g/dL
Total bilirubin ≤ 1.5 x ULN
AST and ALT ≤ 3.0 x ULN
Serum Creatinine ≤ 1.5x ULN

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation
in this study
Inability to comply with study and follow-up procedures
Significant cardiovascular disease, such as New York Heart Association cardiac disease
(Class II or greater), myocardial infarction within the past 3 months, unstable
arrhythmias, or unstable angina
Known clinically significant liver disease defined as AST and ALT > 3.0 x ULN and/or
Total bilirubin > or = 1.5 x ULN, or documented history of active viral, alcoholic, or
other hepatitis, cirrhosis, and inherited liver disease
Participation in investigational clinical trial within last 30 days
History of significant chronic disease including HIV/AIDS or hepatitis C
Inability to provide informed consent
Known CNS malignancy or CNS metastases
Patients with previous malignancy, other than endometrial, within the past 2 years
from cycle 1, day 1, with the exception of those with negligible risk of metastasis or
death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma
of the skin or carcinoma in situ of the breast
History of stroke or transient ischemic attack (TIA) within 3 months prior to cycle 1
day 1(C1D1)
Women with prognosis for survival less than 6 months
Patients who have progressed or have stable disease (SD) through most recent
chemotherapy regimen
Patients deemed otherwise clinically unfit for clinical trial per Investigator's
discretion
Patients with duodenal stent or other GI disorder/defect that would interfere with
absorption of oral medication
Female patients who maintain fertility potential and refuse to comply to use
contraception and be followed for pregnancy by pregnancy testing
Minor surgical procedure < or = 14 days or major surgeries < or = 28 days prior to
first dose of treatment
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How to participate?

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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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